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Effect of a Reducose®-Based Supplement on Metabolic Health in Subjects With Metabolic Syndrome

NCT07451639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-05

No results posted yet for this study

Summary

This study tests whether a mulberry leaf extract can help adults with early cardiometabolic risk lose more weight while taking metformin.

People with cardiometabolic risk often have excess body weight, higher blood sugar, and changes in blood fats. Many take metformin to help control blood sugar. Researchers wanted to see if adding a mulberry leaf supplement could improve weight loss and support overall metabolic health.

Adults could take part if they:

* Were overweight (body mass index over 25)
* Had early signs of metabolic risk
* Had been taking metformin 1000 mg daily for at least six months

The study lasted 12 weeks. Fifty adults took part. Participants were randomly assigned, like flipping a coin, to receive either:

* Mulberry leaf extract (250 mg twice daily), or
* A placebo, which looks the same but contains no active ingredient

Participants took the capsules 10 minutes before lunch and dinner. They continued their usual diet and physical activity. Researchers contacted participants each month to check capsule use and monitor safety.

The main goal was to measure changes in:

* Body weight
* Body mass index
* Waist size

Researchers also measured blood sugar, cholesterol, liver health, and quality of life.

The study aimed to find out whether adding mulberry leaf extract to stable metformin treatment could lead to greater weight loss and support metabolic health compared to placebo.

Conditions

Interventions

DIETARY_SUPPLEMENT

Mulberry Leaf Extract

he active supplement was Glicoper® (Pharmaluce S.r.l., Republic of San Marino\[PJ1\] ), containing Reducose® (Phynova Group Ltd, Oxford, UK), a proprietary aqueous extract of Morus alba L. leaves. Each capsule contained 250 mg of extract (12.5 mg DNJ). Participants assigned to the intervention group consumed one capsule before lunch and one before dinner, resulting in a total daily DNJ intake of 25 mg.

DIETARY_SUPPLEMENT

Placebo

Placebo capsules matched the active product in appearance, weight, and fill volume and contained microcrystalline cellulose. All capsules were manufactured under GMP conditions and supplied by Erbozeta S.p.A.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-03-01
Completion
2024-06-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07451639 on ClinicalTrials.gov